MINIMED® PRO-SET® BD FLOWSMART¿ TECHNOLOGY, 24IN X 6MM P-CAP
Received Feb 15, 2019 · Event occurred Aug 4, 2017
Report 1920898-2019-00163 · MDR key 8344429
Device
Generic name
Intravascular Administration Set
Manufacturer
Bd Medical - Diabetes CareCatalog number
328614
Lot number
6207535
Product problems
- Failure to Deliver
- Failure to Deliver
Patient
Not reported
- No Information
- No Information
Narrative
Additional Manufacturer Narrative
(B)(6). A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION AND/OR DEVICE HISTORY REVIEW, A SUPPLEMENTAL REPORT WILL BE FILED.
Description of Event or Problem
IT WAS REPORTED THAT DURING USE OF A MINIMED® PRO-SET® BD FLOWSMART¿ TECHNOLOGY, 24IN X 6MM P-CAP THE NEEDLE WAS BENT AND WOULD NOT DELIVER INSULIN.
Additional Manufacturer Narrative
INVESTIGATION: THERE WERE NO RELEVANT QUALITY NOTIFICATIONS RAISED WHICH MAY HAVE CONTRIBUTED TO BENT CANNULA FOUND DURING DHR REVIEW. SINCE THERE WERE NO SAMPLES (OR PHOTOS) FOR INVESTIGATION, UNABLE TO CONFIRM THE REPORTED ISSUE AND THE ACTUAL ROOT CAUSE IS UNDETERMINED.
Description of Event or Problem
IT WAS REPORTED THAT DURING USE OF A MINIMED® PRO-SET® BD FLOWSMART¿ TECHNOLOGY, 24 IN X 6MM P-CAP THE NEEDLE WAS BENT AND WOULD NOT DELIVER INSULIN.